[Federal Register Volume 75, Number 116 (Thursday, June 17, 2010)]
[Notices]
[Pages 34452-34453]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-14637]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2010-N-0279]
Center for Drug Evaluation and Research Data Standards Plan;
Availability for Comment
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability for public comment of the draft document entitled ``CDER
Data Standards Plan Version 1.0'' (draft plan). The draft plan outlines
the general approach proposed for development of a comprehensive data
standards program in the Center for Drug Evaluation and Research
(CDER). The draft plan identifies key objectives for a data standards
program at CDER, processes to be developed to ensure successful use of
those standardized data, and a set of recommended projects to begin in
calendar year (CY) 2010.
DATES: Submit either electronic or written comments on the draft plan
by September 15, 2010.
ADDRESSES: Submit written requests for single copies of the draft plan
to the Division of Drug Information, Center for Drug Evaluation and
Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg.
51, rm. 2201, Silver Spring, MD 20993-0002. Send one self-addressed
adhesive label to assist that office in processing your requests. See
the SUPPLEMENTARY INFORMATION section for electronic access to the
draft plan.
Submit electronic comments on the draft plan to http://www.regulations.gov. Submit written comments to the Division of Dockets
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane,
rm. 1061, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT: Ranjit Thomas, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, rm. 1166, Silver Spring, MD 20993-0002, e-
mail: [email protected].
SUPPLEMENTARY INFORMATION:
I. Background
FDA receives an enormous and growing amount of data in regulatory
submissions in a variety of formats from many sources. This wealth of
data holds great potential to advance CDER's regulatory and scientific
work, but the present lack of standardized data creates significant
challenges to realizing that potential. A data standards plan would
enhance CDER's ability to efficiently and effectively perform its
critical public health mission.
At present, the lack of standardized data affects CDER's review
processes by curtailing a reviewer's ability to perform integral tasks
such as rapid acquisition, analysis, storage, and reporting of
regulatory data. Standardized data will allow reviewers to increase
review consistency and perform evaluations across the drug lifecycle.
Improved data quality, accessibility, and predictability will give
reviewers more time to carry out complex analyses, ask in-depth
questions, and address late-emerging issues.
Standardization of data submissions, a requirement for electronic
submissions, and a robust computational infrastructure would make
significant improvements possible. Facilitating improvements requires
careful analysis, advanced planning, project management, expert input,
and effective communication among all key stakeholders. To be
successful, a plan is required to identify, develop, adopt, and
maintain data standards that meet CDER ``end user'' needs.
FDA is making available for public comment the draft plan entitled
``CDER
[[Page 34453]]
Data Standards Plan Version 1.0.'' The draft plan is intended to
communicate FDA's approach for establishing a comprehensive data
standards program at CDER and ensuring the development and successful
use of data standards for all key data needed to make regulatory
decisions. FDA will consider comments received in developing future
versions of the plan.
II. Comments
Interested persons may submit to the Division of Dockets Management
(see ADDRESSES) either electronic or written comments regarding this
document. It is only necessary to send one set of comments. It is no
longer necessary to send two copies of mailed comments. Identify
comments with the docket number found in brackets in the heading of
this document. Received comments may be seen in the Division of Dockets
Management between 9 a.m. and 4 p.m., Monday through Friday.
III. Electronic Access
Persons with access to the Internet may obtain the document at
http://www.regulations.gov or http://www.fda.gov/downloads/Drugs/DevelopmentApprovalProcess/FormsSubmissionRequirements/ElectronicSubmissions/UCM214120.pdf.
Dated: June 11, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010-14637 Filed 6-16-10; 8:45 am]
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